Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)
Primary Purpose
Hepatocellular Carcinoma (HCC)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pexastimogene Devacirepvec (Pexa Vec)
Sorafenib
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring Hepatocellular Carcinoma (HCC), Pexastimogene Devacirepvec (Pexa-Vec), Sorafenib, GM-CSF therapy, Thymidine Kinase-Deactivated Vaccinia Virus, Oncology, Recombinant Vaccinia Virus, Oncolytic Virus Therapy, Oncolytic virotherapy
Eligibility Criteria
Inclusion Criteria:
- Histological/cytological diagnosis of primary HCC
- Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
- At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
- Child-Pugh Class A
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate hematological, hepatic, and renal function:
- Additional inclusion criteria exist
Exclusion Criteria:
- Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
- Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
- Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
- History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
- Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
- Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
- Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
- History of severe eczema (as determined by the Investigator) requiring medical treatment
- Additional exclusion criteria exist
Sites / Locations
- University of Alabama
- Mayo Clinic Arizona
- UC Irvine Medical Center
- Stanford University School of Medicine
- University of Florida Shands Hospital
- University of Chicago
- University of Kansas Cancer Center
- University of Louisville
- Tulane University Health Sciences Center
- Mercy Medical Center, Inc.
- University of Minnesota
- Kansas City Research Institute
- Saint Louis University
- Washington University School of Medicine
- Billings Clinic
- Morristown Medical Center
- St. Joseph's Hospital
- Ohio State University
- Hospital of The University of Pennsylvania
- Rhode Island Hospital
- University of Tennessee Medical Center
- University of Texas Southwestern Medical Center
- Benaroya Research Institute at Virginia Mason Hospital
- Site No. 8409
- Site No. 8412
- Site No. 8403
- Site No. 8401
- Site No. 8407
- Site No. 8406
- Site No. 8408
- Site No. 8405
- Site No. 8414
- Site No. 8411
- Site No. 8402
- Site No. 8415
- Site No. 8413
- University of Alberta Hospital
- Juravinski Cancer Centre
- Sunnybrook Health Sciences Centre
- Site 8829
- Site No. 8821
- Site 8811
- Site 8820
- Site No.8816
- Site 8827
- Site No.8828
- Site 8832
- Site No. 8802
- Site 8805
- Site No. 8808
- Site No.8815
- Site No. 8801
- Site 8833
- Site 8806
- Site 8822
- Site 8831
- Site No. 8823
- Site No. 8825
- Site No. 9013
- Site No. 9005
- Site No. 9003
- Site No. 9006
- Site 9012
- Site No. 9008
- Site No. 9010
- Site No. 9007
- Site No. 9014
- Site No. 9011
- Site No. 9001
- Site No. 9002
- Site No. 9009
- Site No. 9111
- Site No. 9113
- Site No. 9109
- Site No. 9108
- Site No. 9106
- Site No 9105
- Site No. 9112
- Site No. 9101
- Site No. 9102
- Site No. 9104
- Site No. 9110
- Site No. 8601
- Site No. 9707
- Site 9704
- Site No. 9702
- Site No. 9705
- Site No. 9703
- Site No. 9706
- Site No.9205
- Site No. 9204
- Site No. 9201
- Site No. 9203
- Site No. 8208
- Site No. 8211
- Site No. 8201
- Site 8216
- Site No. 8207
- Site No. 8213
- Site No. 8220
- Site 8224
- Site No. 8221
- Site No. 8218
- Site No. 8219
- Site No. 8222
- Site No. 8202
- Site No. 8203
- Site No. 8205
- Site No. 8209
- Site No. 8212
- Site No. 8215
- Site No. 8223
- Site No. 8210
- Site No. 8217
- Auckland City Hospital
- Site No. 8902
- Site No. 9404
- Site No. 9405
- Site No. 9403
- Site No. 9401
- Site No. 9402
- Site 8702
- Site 8703
- Site No. 8701
- Site No. 8305
- Site No. 8307
- Site No. 8306
- Site No. 8302
- Site No. 8301
- Site No. 8303
- Site No. 8502
- Site No. 8505
- Site No. 8503
- Site No. 8507
- Site No. 8501
- Site No. 8506
- Site No. 9501
- Site No. 9505
- Site No. 9503
- Site No. 9502
- Site No. 9504
- Site No. 9506
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pexa-Vec followed by Sorafenib
Sorafenib
Arm Description
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Sorafenib (400 mg twice daily) begins on Day 1.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02562755
Brief Title
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Acronym
PHOCUS
Official Title
A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SillaJen, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
Detailed Description
This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.
A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)
Keywords
Hepatocellular Carcinoma (HCC), Pexastimogene Devacirepvec (Pexa-Vec), Sorafenib, GM-CSF therapy, Thymidine Kinase-Deactivated Vaccinia Virus, Oncology, Recombinant Vaccinia Virus, Oncolytic Virus Therapy, Oncolytic virotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pexa-Vec followed by Sorafenib
Arm Type
Experimental
Arm Description
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib (400 mg twice daily) begins on Day 1.
Intervention Type
Biological
Intervention Name(s)
Pexastimogene Devacirepvec (Pexa Vec)
Other Intervention Name(s)
JX-594
Intervention Description
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Time Frame
From date of randomization to the date of first documented radiographic tumor progression up to 53 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological/cytological diagnosis of primary HCC
Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
Child-Pugh Class A
Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Adequate hematological, hepatic, and renal function:
Additional inclusion criteria exist
Exclusion Criteria:
Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
History of severe eczema (as determined by the Investigator) requiring medical treatment
Additional exclusion criteria exist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SillaJen Medical
Organizational Affiliation
SillaJen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mercy Medical Center, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
St. Joseph's Hospital
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site No. 8409
City
Adelaide
Country
Australia
Facility Name
Site No. 8412
City
Adelaide
Country
Australia
Facility Name
Site No. 8403
City
Brisbane
Country
Australia
Facility Name
Site No. 8401
City
Camperdown
Country
Australia
Facility Name
Site No. 8407
City
Clayton
Country
Australia
Facility Name
Site No. 8406
City
Concord
Country
Australia
Facility Name
Site No. 8408
City
Fitzroy
Country
Australia
Facility Name
Site No. 8405
City
Footscray
Country
Australia
Facility Name
Site No. 8414
City
Heidelberg
Country
Australia
Facility Name
Site No. 8411
City
Melbourne
Country
Australia
Facility Name
Site No. 8402
City
Parkville
Country
Australia
Facility Name
Site No. 8415
City
Perth
Country
Australia
Facility Name
Site No. 8413
City
Sydney
Country
Australia
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Site 8829
City
Changchun
Country
China
Facility Name
Site No. 8821
City
Changsha
Country
China
Facility Name
Site 8811
City
Fuzhou
Country
China
Facility Name
Site 8820
City
Fuzhou
Country
China
Facility Name
Site No.8816
City
Guangdong
Country
China
Facility Name
Site 8827
City
Guangzhou
Country
China
Facility Name
Site No.8828
City
Guangzhou
Country
China
Facility Name
Site 8832
City
Hangzhou
Country
China
Facility Name
Site No. 8802
City
Harbin
Country
China
Facility Name
Site 8805
City
Hefei
Country
China
Facility Name
Site No. 8808
City
Hefei
Country
China
Facility Name
Site No.8815
City
Hefei
Country
China
Facility Name
Site No. 8801
City
Nanjing
Country
China
Facility Name
Site 8833
City
Qingdao
Country
China
Facility Name
Site 8806
City
Shanghai
Country
China
Facility Name
Site 8822
City
Shanghai
Country
China
Facility Name
Site 8831
City
Shanghai
Country
China
Facility Name
Site No. 8823
City
Xi'an
Country
China
Facility Name
Site No. 8825
City
Xi'an
Country
China
Facility Name
Site No. 9013
City
Bondy
Country
France
Facility Name
Site No. 9005
City
Bordeaux
Country
France
Facility Name
Site No. 9003
City
Créteil
Country
France
Facility Name
Site No. 9006
City
Lille
Country
France
Facility Name
Site 9012
City
Montpellier
Country
France
Facility Name
Site No. 9008
City
Nantes
Country
France
Facility Name
Site No. 9010
City
Nice
Country
France
Facility Name
Site No. 9007
City
Paris
Country
France
Facility Name
Site No. 9014
City
Paris
Country
France
Facility Name
Site No. 9011
City
Rennes
Country
France
Facility Name
Site No. 9001
City
Strasbourg
Country
France
Facility Name
Site No. 9002
City
Toulouse
Country
France
Facility Name
Site No. 9009
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Site No. 9111
City
Aachen
Country
Germany
Facility Name
Site No. 9113
City
Bonn
Country
Germany
Facility Name
Site No. 9109
City
Dresden
Country
Germany
Facility Name
Site No. 9108
City
Frankfurt am Main
Country
Germany
Facility Name
Site No. 9106
City
Hamburg
Country
Germany
Facility Name
Site No 9105
City
Hannöver
Country
Germany
Facility Name
Site No. 9112
City
Heidelberg
Country
Germany
Facility Name
Site No. 9101
City
Mainz
Country
Germany
Facility Name
Site No. 9102
City
München
Country
Germany
Facility Name
Site No. 9104
City
Tübingen
Country
Germany
Facility Name
Site No. 9110
City
Ulm
Country
Germany
Facility Name
Site No. 8601
City
Hong Kong
Country
Hong Kong
Facility Name
Site No. 9707
City
Afula
Country
Israel
Facility Name
Site 9704
City
Haifa
Country
Israel
Facility Name
Site No. 9702
City
Haifa
Country
Israel
Facility Name
Site No. 9705
City
Jerusalem
Country
Israel
Facility Name
Site No. 9703
City
Ramat-Gan
Country
Israel
Facility Name
Site No. 9706
City
Tel Aviv
Country
Israel
Facility Name
Site No.9205
City
Modena
Country
Italy
Facility Name
Site No. 9204
City
Napoli
Country
Italy
Facility Name
Site No. 9201
City
Palermo
Country
Italy
Facility Name
Site No. 9203
City
Parma
Country
Italy
Facility Name
Site No. 8208
City
Ansan
Country
Korea, Republic of
Facility Name
Site No. 8211
City
Bucheon
Country
Korea, Republic of
Facility Name
Site No. 8201
City
Busan
Country
Korea, Republic of
Facility Name
Site 8216
City
Daegu
Country
Korea, Republic of
Facility Name
Site No. 8207
City
Daegu
Country
Korea, Republic of
Facility Name
Site No. 8213
City
Daegu
Country
Korea, Republic of
Facility Name
Site No. 8220
City
Daegu
Country
Korea, Republic of
Facility Name
Site 8224
City
Goyang
Country
Korea, Republic of
Facility Name
Site No. 8221
City
Jinju-si
Country
Korea, Republic of
Facility Name
Site No. 8218
City
Pusan
Country
Korea, Republic of
Facility Name
Site No. 8219
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Site No. 8222
City
Seongnam
Country
Korea, Republic of
Facility Name
Site No. 8202
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8203
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8205
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8209
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8212
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8215
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8223
City
Seoul
Country
Korea, Republic of
Facility Name
Site No. 8210
City
Suwon
Country
Korea, Republic of
Facility Name
Site No. 8217
City
Ulsan
Country
Korea, Republic of
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Site No. 8902
City
Christchurch
Country
New Zealand
Facility Name
Site No. 9404
City
Coimbra
Country
Portugal
Facility Name
Site No. 9405
City
Coimbra
Country
Portugal
Facility Name
Site No. 9403
City
Lisboa
Country
Portugal
Facility Name
Site No. 9401
City
Porto
Country
Portugal
Facility Name
Site No. 9402
City
Porto
Country
Portugal
Facility Name
Site 8702
City
Singapore
Country
Singapore
Facility Name
Site 8703
City
Singapore
Country
Singapore
Facility Name
Site No. 8701
City
Singapore
Country
Singapore
Facility Name
Site No. 8305
City
Kaohsiung
Country
Taiwan
Facility Name
Site No. 8307
City
Linkou
Country
Taiwan
Facility Name
Site No. 8306
City
Taichung
Country
Taiwan
Facility Name
Site No. 8302
City
Tainan City
Country
Taiwan
Facility Name
Site No. 8301
City
Taipei
Country
Taiwan
Facility Name
Site No. 8303
City
Taipei
Country
Taiwan
Facility Name
Site No. 8502
City
Bangkok
Country
Thailand
Facility Name
Site No. 8505
City
Bangkok
Country
Thailand
Facility Name
Site No. 8503
City
Chiang Mai
Country
Thailand
Facility Name
Site No. 8507
City
Hat Yai
Country
Thailand
Facility Name
Site No. 8501
City
Khon Kaen
Country
Thailand
Facility Name
Site No. 8506
City
Phitsanulok
Country
Thailand
Facility Name
Site No. 9501
City
Birmingham
Country
United Kingdom
Facility Name
Site No. 9505
City
Guildford
Country
United Kingdom
Facility Name
Site No. 9503
City
Leeds
Country
United Kingdom
Facility Name
Site No. 9502
City
London
Country
United Kingdom
Facility Name
Site No. 9504
City
London
Country
United Kingdom
Facility Name
Site No. 9506
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
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